An interventional study of Care to Plan and Usual Care in Dementia, Alzheimer Disease and Memory Loss, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-02.
Sponsored by University of Minnesota · Not applicable, Interventional, and Supportive care
The present study will refine and conduct a preliminary efficacy evaluation of Care to Plan. Care to Plan is an online care planning tool that provides a succinct and clear overview of various types of dementia caregiver interventions, administers a brief validated assessment of risk, and generates individualized recommendations for dementia caregivers as well as resources that link users to a selected recommendation.
There remains a lack of individualized information that can directly meet the diverse needs of caregivers or their relatives with Alzheimer's disease or a related dementia (ADRD). This project will advance scientific knowledge, technical capability, and clinical practice as they pertain to ADRD management and caregiver support.
Given the well-documented health implications of dementia family caregiving, existing interventions are designed to modify the more challenging aspects of care for a relative with Alzheimer's disease or a related dementia (ADRD) in order to improve key outcomes. However, current research has yet to discern which caregivers are most likely to benefit from different types of interventions or services. There also remains a lack of individualized information that can directly meet the heterogeneous needs of caregivers or their relatives with ADRD. This project will advance scientific knowledge, technical capability, and clinical practice as they pertain to ADRD management and caregiver support. The research team has developed and tested the feasibility and utility of an online care planning tool prototype (called Care to Plan, or CtP) that provides a succinct and clear overview of various types of ADRD caregiver interventions, administers a brief validated assessment of risk, and generates individualized service recommendations for ADRD caregivers as well as resources that link users to a selected recommendation. The goal of CtP is to offer a more efficient, user-directed process to link ADRD caregivers to the services that may be most appropriate for them given their needs, the needs of their relatives, and other contextual characteristics. We will deploy and more fully evaluate CtP for family caregivers of persons with ADRD who seek services in Riverside Health System (RHS) in the state of Virginia. The Specific Aims are to: 1) Implement CtP for 20 family members of persons with ADRD in four RHS clinical sites (Phase I) over a 1-month period; and 2) Evaluate the preliminary efficacy and implementation of CtP (Phase II) via an embedded randomized controlled evaluation for 100 newly enrolled ADRD caregivers over a 6-month period. We anticipate that the CtP will serve as an innovative, low-cost tool that both families and long-term service and support providers can utilize to better meet the diverse needs of family caregivers of persons with ADRD in their communities.
2,230 studies on the registry are indexed under Dementia; 549 are open to participants now.
This study's enrollment of 65 is below the median of 83 across 1,669 interventional studies indexed under Dementia.
Browse Dementia studies →University of Minnesota is the lead sponsor of 1,210 studies on the registry; 195 are open to participants now.
Of its 133 completed or terminated interventional studies of FDA-regulated products, 92 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: The care recipient has received a provider diagnosis of Alzheimer's disease or a related dementia (ADRD); and 2) the caregiver is 21 years of age or older; 3) English-speaking; 4) self-identifies as someone who provides help to the person with ADRD because of their cognitive impairments; 5) the caregiver indicates a willingness to use Care to Plan (CtP); and 6) caregiver resides in one of 4 Riverside Health regions (based on zip code).
Exclusion Criteria: Those who do not meet the inclusion criteria above are not eligible. Additionally, those who endorse a history of a serious mental health disorder whose: a) symptoms have exacerbated in the last six months, and b) are not receiving steady, ongoing pharmacological or other treatment for these symptoms, will be excluded from the project.
Participants randomized to this treatment arm will receive the Care to Plan (CtP) intervention as a part of Phase II.
Behavioral: Care to Plan
Participants randomized to a usual care control group as a part of Phase II. Note: If eligible, participants in this control group will be asked if they are interested in enrolling in a similar, additional feature of the study to test the Care to Plan tool following the initial 6-month study.
Behavioral: Usual Care
Participants enrolled in Phase I of the project to receive the intervention \[non-randomized; no comparison group\].
Behavioral: Care to Plan
Care to Plan (CtP) is an online care planning tool that provides a succinct and clear overview of various types of ADRD caregiver interventions, administers a brief validated assessment of risk, and generates individualized service recommendations for Alzheimer's disease and related dementia (ADRD) caregivers as well as resources that link users to a selected recommendation. Caregivers will complete the tool with the guidance of a CtP interventionist (Senior Care Navigator/Riverside Health System staff). The interventionist will discuss CtP recommendations with caregivers and help caregivers enroll in a recommended support service if so desired.
Receive care as usual. Note: If eligible, participants in this control group will be asked if they are interested in enrolling in a similar, additional feature of the study to test the Care to Plan tool following the initial 6-month study.
Caregiver Self-efficacy
Eight-item survey developed by Fortinsky and colleagues. Responses for each item range from 1 (Very unconfident) to 5 (Very confident), with higher scores indicating greater self-efficacy. The 8-item responses are averaged. Mean of participant scores is reported.
Time frame: Phase II Baseline, 3-months, 6-months
Care to Plan Service Use
This author-developed scale is a self-report of a various services used over a 3 month period. Service types include Skills building, Problem solving, Take a break, Brain health, Support groups, Change your thinking, High powered combinations, and Other. The total number of services used are summed (ranging 0 to 8, with higher numbers indicating greater service use). The average of participant responses is reported.
Time frame: Phase II Baseline, 3-months, 6-months
Phase II - Caregiver Distress: Role Overload
A 3-item scale measuring caregivers' feelings of emotional fatigue. Item responses range from 1 = strongly disagree to 5 = strong agree. Item responses are averaged, with higher score representing greater role overload.
Time frame: Phase II Baseline, 3-months, 6-months
Primary Subjective Stressors: Loss of Intimate Exchange
3-items addressing relationship with relative. Responses include Very much (4), Somewhat (3), Just a little (2), Not at all (1), with higher scores indicating greater loss. Mean of the 3 items is analyzed. Overall mean of participants is reported.
Time frame: Phase II Baseline, 3-month, 6-month
Caregiver Distress: Role Captivity
3-items assessing the involuntary aspects of the caregiving role. Responses for each item include: Very much (4), Somewhat (3), Just a little (2), Not at all (1), with higher score representing greater role captivity. Mean of the 3 items is analyzed. Overall mean of participants is reported.
Time frame: Phase II Baseline, 3-months, 6-months
Center for Epidemiological Studies Depression (CES-D)
The 20-item Center for Epidemiological Studies Depression (CES-D) survey measure is used to assess respondents' depressive symptoms. Each of the 20 items is scored from 0 = Rarely or none of the time (less than 1 day) to 3 = Most of the time (5-7 days), with 4 items reverse coded. The total CES-D score is summed (ranging 0-60), with higher scores representing more frequent depressive symptoms. Results are reported as a mean of participant scores.
Time frame: Phase II Baseline, 3-months, 6-months
Acceptability and Feasibility
This is an author-developed 21-item scale assessing the acceptability and feasibility of the intervention. Response options include Strongly Disagree (1), Disagree (2), Neutral (3), Agree (4), and Strongly Agree (5), or not applicable; 4 items are reverse coded. Higher scores indicate greater acceptability and feasibility of the tool. The summary score represents a mean of the 21-items.
Time frame: Phase I at 1-month follow up
| Milestone | Phase I: Treatment [Non-randomized] | Phase II: Treatment [Randomized] | Phase II: Control [Randomized] |
|---|---|---|---|
| Started | 20 | 22 | 21 |
| Completed | 20 | 21 | 20 |
| Not completed | 0 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
Eight-item survey developed by Fortinsky and colleagues. Responses for each item range from 1 (Very unconfident) to 5 (Very confident), with higher scores indicating greater self-efficacy. The 8-item responses are averaged. Mean of participant scores is reported.
| scores on a scale | Phase II [Randomized]: Treatment | Phase II [Randomized]: Control |
|---|---|---|
| Baseline [Phase II] | 3.62 ± .85 | 3.36 ± .74 |
| 3-months [Phase II] | 3.84 ± .96 | 3.57 ± .88 |
| 6-months [Phase II] | 3.58 ± .73 | 3.55 ± .70 |
This author-developed scale is a self-report of a various services used over a 3 month period. Service types include Skills building, Problem solving, Take a break, Brain health, Support groups, Change your thinking, High powered combinations, and Other. The total number of services used are summed (ranging 0 to 8, with higher numbers indicating greater service use). The average of participant responses is reported.
| services | Phase II[Randomized]: Treatment | Phase II [Randomized]: Control |
|---|---|---|
| Baseline [Phase II] | 2.69 ± 1.25 | 2.62 ± 1.32 |
| 3-month [Phase II] | 3.00 ± 0.88 | 2.56 ± 1.69 |
| 6-month [Phase II] | 2.31 ± 1.20 | 2.25 ± 1.07 |
A 3-item scale measuring caregivers' feelings of emotional fatigue. Item responses range from 1 = strongly disagree to 5 = strong agree. Item responses are averaged, with higher score representing greater role overload.
| score on a scale (mean) | Phase II [Randomized]: Treatment | Phase II [Randomized]: Control |
|---|---|---|
| Baseline [Phase II] | 3.23 ± 1.28 | 3.71 ± 1.05 |
| 3-month [Phase II] | 3.18 ± 1.14 | 3.56 ± 1.00 |
| 6-month [Phase II] | 3.15 ± 1.10 | 3.77 ± .85 |
3-items addressing relationship with relative. Responses include Very much (4), Somewhat (3), Just a little (2), Not at all (1), with higher scores indicating greater loss. Mean of the 3 items is analyzed. Overall mean of participants is reported.
| score on a scale (mean) | Phase II [Randomized]: Treatment | Phase II [Randomized]: Control |
|---|---|---|
| Baseline [Phase II] | 3.30 ± .92 | 2.86 ± .93 |
| 3-month [Phase II] | 3.25 ± .97 | 2.98 ± .86 |
| 6-month [Phase II] | 3.35 ± .82 | 3.13 ± .82 |
3-items assessing the involuntary aspects of the caregiving role. Responses for each item include: Very much (4), Somewhat (3), Just a little (2), Not at all (1), with higher score representing greater role captivity. Mean of the 3 items is analyzed. Overall mean of participants is reported.
| score on a scale (mean) | Phase II [Randomized]: Treatment | Phase II [Randomized]: Control |
|---|---|---|
| Baseline [Phase II] | 1.97 ± .93 | 2.27 ± .83 |
| 3-month [Phase II] | 1.98 ± 1.03 | 2.17 ± .77 |
| 6-month [Phase II] | 1.94 ± .95 | 2.29 ± 1.03 |
The 20-item Center for Epidemiological Studies Depression (CES-D) survey measure is used to assess respondents' depressive symptoms. Each of the 20 items is scored from 0 = Rarely or none of the time (less than 1 day) to 3 = Most of the time (5-7 days), with 4 items reverse coded. The total CES-D score is summed (ranging 0-60), with higher scores representing more frequent depressive symptoms. Results are reported as a mean of participant scores.
| score on a scale | Phase II [Randomized]: Treatment | Phase II [Randomized]: Control |
|---|---|---|
| Baseline [Phase II] | 15.73 ± 7.11 | 19.10 ± 7.52 |
| 3-month [Phase II] | 18.47 ± 8.39 | 21.50 ± 7.80 |
| 6-month [Phase II] | 18.19 ± 7.28 | 20.50 ± 7.21 |
This is an author-developed 21-item scale assessing the acceptability and feasibility of the intervention. Response options include Strongly Disagree (1), Disagree (2), Neutral (3), Agree (4), and Strongly Agree (5), or not applicable; 4 items are reverse coded. Higher scores indicate greater acceptability and feasibility of the tool. The summary score represents a mean of the 21-items.
| score on a scale (mean) | Phase I [Non-randomized]: Treatment |
|---|---|
| Acceptability and Feasibility | 4.22 ± 0.69 |
Collected over Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase II [Randomized]: Treatment | 0/22 (0%) | 1/22 (4.5%) | 7/22 (31.8%) |
| Phase II [Randomized]: Control | 0/21 (0%) | 0/21 (0%) | 4/21 (19%) |
| Phase I [Non-randomized]: Treatment | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Event | Phase II [Randomized]: Treatment | Phase II [Randomized]: Control | Phase I [Non-randomized]: Treatment |
|---|---|---|---|
| UTIRenal and urinary disorders | 1/22 | 0/21 | 0/20 |
| Event | Phase II [Randomized]: Treatment | Phase II [Randomized]: Control | Phase I [Non-randomized]: Treatment |
|---|---|---|---|
| COVIDInfections and infestations | 2/22 | 0/21 | 0/20 |
| Hip issue [unspecified]Musculoskeletal and connective tissue disorders | 0/22 | 1/21 | 0/20 |
| HypertensionCardiac disorders | 0/22 | 1/21 | 0/20 |
| Back painMusculoskeletal and connective tissue disorders | 0/22 | 1/21 | 0/20 |
| Unknown/not specified medical concernGeneral disorders | 0/22 | 1/21 | 0/20 |
| Initiate Anxiety MedicationPsychiatric disorders | 1/22 | 0/21 | 0/20 |
| Initiate Thyroid MedicationEndocrine disorders | 1/22 | 0/21 | 0/20 |
| Eye surgeryEye disorders | 1/22 | 0/21 | 0/20 |
| Multiple falls during studyMusculoskeletal and connective tissue disorders | 1/22 | 0/21 | 0/20 |
| Vulnerable adult reportGeneral disorders | 1/22 | 0/21 | 0/20 |
| Age, Continuous(years) | Treatment [Randomized] | Control [Randomized] | Phase I: Treatment [Non-randomized] | Total |
|---|---|---|---|---|
| Mean | 52.33 ± 16.54 | 63.38 ± 11.77 | 66.68 ± 11.43 | 63.24 ± 12.42 |
| Sex: Female, Male(Participants) | Treatment [Randomized] | Control [Randomized] | Phase I: Treatment [Non-randomized] | Total |
|---|---|---|---|---|
| Female | 17 | 15 | 18 | 50 |
| Male | 5 | 6 | 2 | 13 |
| Ethnicity (NIH/OMB)(Participants) | Treatment [Randomized] | Control [Randomized] | Phase I: Treatment [Non-randomized] | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 22 | 21 | 20 | 63 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment [Randomized] | Control [Randomized] | Phase I: Treatment [Non-randomized] | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 4 | 5 | 12 |
| White | 18 | 17 | 15 | 50 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Public access to the research data generated from this project will be offered via de-identified data files maintained by the investigators. All personal identifiers of family caregivers of persons with Alzheimer's disease or a related dementia (ADRD) participating in the study will be removed and replaced with random identification numbers prior to distributing data files. Dr. Gaugler plans to maintain all data from the proposed project on the secure School of Public Health shared server folder for 7 years following study completion. Potential external investigators will be asked to complete a data use agreement and a recommended citation to these materials will be provided. Dr. Gaugler will oversee the distribution of public data during the course of the funding period and for an indefinite time thereafter.
Ran from Sep 2019 to primary completion in May 2022, 32 months.
Results were first posted in Jun 2023, 1 year after primary completion.
Of 835 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 32 months is above that.
Counting every sponsor, half of 875 studies reached it within 24 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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